An interventional study of SPF 50 Y49 091 (BAY 987516) and SPF 50 X15 158 (BAY 987516) in Sunscreening Agents, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.
Sponsored by Bayer · Not applicable, Interventional, and Other
The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products [Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Inclusion Criteria:
Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.
Drug: SPF 50 Y49 091 (BAY 987516) · Other: J & J baby shampoo, X46 046 (control)
Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.
Drug: SPF 50 X15 158 (BAY 987516) · Other: J & J baby shampoo, X46 046 (control)
Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.
Drug: SPF 50 X15 160 (BAY 987516) · Other: J & J baby shampoo, X46 046 (control)
Subjects were given the control article (standard shampoo mixture, X46 046) in one eye and one of the test articles in the other eye according to the randomization schedule.
Drug: SPF 50 X57 162 (BAY 987516) · Other: J & J baby shampoo, X46 046 (control)
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
Subjective discomfort
Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article
Time frame: up to 10 days
Objective lacrimation
Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow
Time frame: up to 10 days
Objective conjunctival inflammation
Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids
Time frame: up to 10 days
Objective cornea and iris inflammation
Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding or pitting of cornea and/or thickening of the iris
Time frame: up to 10 days
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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